Medical Affairs Professional (m/f/d) - Part-Time, 21 Hours per Week

About the role

**Engineering and IT Projects with Real Impact - Build Your Career at Cs2 ITEC** Are you looking for challenging industrial projects where you can apply your technical expertise without being limited by rigid corporate structures? Then Cs2 ITEC could be the right place for you. Cs2 ITEC is a specialized engineering and IT service provider connecting skilled professionals with exciting project opportunities at leading industrial companies. Our focus areas include energy, automation, electrical engineering, plant engineering, aerospace, automotive, and information technology. With us, you can expect more than anonymous placement. We believe in long-term collaboration: you are employed by Cs2 ITEC, work on carefully selected client projects, and receive personal support throughout your assignment. **Your Responsibilities:** As a **Medical Affairs Professional (m/f/d)** in a part-time role, you will support the medical-scientific evaluation of **MRI products** as a parental leave replacement. You will work closely with Clinical Solutions, product lines, Research & Development, and Quality to help ensure the clinical safety, performance, and regulatory compliance of innovative medical devices. - Provide sound medical and clinical input for product design, regulatory decision-making, and the further development of medical devices. - Drive the evaluation of clinical safety and performance, define clinical claims, and assess their clinical relevance. - Advise authors of clinical evaluations, review and verify clinical evidence, and take ownership of project-related reviews and approvals in line with Quality Management System (QMS) requirements. - Develop clinical study protocols based on scientific standards and market-specific regulatory requirements. - Support requirements engineering, health risk assessment, and the evaluation of MRI products by providing medical advice and clinical assessment to ensure that clinical requirements are met. - Contribute to the investigation of customer complaints and assess customer feedback from a medical and clinical perspective. - Represent your area of responsibility in internal and external meetings, stakeholder communications, and audits. - Proactively monitor medical trends, emerging technologies, regulatory changes, and best practices in clinical research and clinical evaluation methodologies. **Your Profile:** - You hold a completed degree in medicine at master's level or higher; ideally, you have completed specialist training in radiology. - You have at least two years of professional experience in the relevant field and bring extensive hands-on experience as a physician in a clinical environment. - You are preferably familiar with the fundamentals of the Medical Device Regulation (MDR) and the requirements for clinical evaluations of medical devices. - You have proven experience in writing and publishing scientific articles in peer-reviewed journals as well as in conducting clinical studies. - You bring strong presentation and communication skills and can explain complex medical and regulatory topics clearly, convincingly, and appropriately for different audiences. - You demonstrate strong analytical thinking and are able to approach complex topics in a structured, solution-oriented, and transparent way. - You work proactively, independently, and with a strong focus on results. - You are a committed team player who enjoys interdisciplinary collaboration and actively contributes to maintaining high quality standards within the team. - You are fluent in business English and communicate confidently with different business functions, cultures, and management levels in an international environment. German language skills are an advantage. **Does this sound like the right opportunity for you?** I look forward to receiving your application. I would be happy to speak with you about your technical expertise, your expectations for your next career step, and the specific project opportunities available at Cs2 ITEC. Cs2 ITEC welcomes applications from all qualified candidates, regardless of gender, age, disability, nationality, ethnic or social background, religion or belief, sexual orientation, or identity.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Cs2 ITEC GmbH Co. KG? Share your experience